Assoc Dir. - Vaccine Analytical Projects and Process Improvements

MSD Malaysia

Northern (KY)

Hybrid

USD 142,000 - 224,000

Full time

4 days ago
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Job summary

Merck seeks an Associate Director to lead a team of scientists handling vaccine-focused analytical projects in West Point, PA. You will drive method lifecycle activities, including validation, transfers, and instrument modernization within GMP QC testing.

Strong people leadership and cross-functional execution are essential to align with Quality, Regulatory, and external partners in a fast-paced laboratory environment.

Qualifications

  • Bachelor’s degree with 8+ years, Master’s with 6+ years, or PhD with 4+ years in vaccine analytical testing or related fields.
  • Experience leading scientific or technical teams, including coaching and performance management.
  • Strong GMP QC analytical testing background, preferably in commercial vaccine products.
  • Experience with analytical method lifecycle management, validation, transfer, and change implementation.

Responsibilities

  • Lead a team of scientists responsible for vaccine-focused analytical projects in GMP QC labs.
  • Oversee method transfers, validations, instrument replacements, and method modernization initiatives.
  • Provide leadership, project prioritization, and escalation support across multiple functional areas.
  • Collaborate with West Point Quality Laboratories, regulatory, manufacturing, and external partners to ensure compliant vaccine testing.

Skills

Analytical Chemistry
Bioanalytical Analysis
Method Development
Method Validation
Project Management
People Leadership
GMP Quality Control
Change Control
DOE
Data Analysis
Instrument Qualification
Technical Transfer

Education

Bachelor’s degree
Master’s degree
PhD

Job description

Job Description

We are seeking an Associate Director to lead a team of scientists responsible for vaccine-focused analytical projects supporting vaccine quality control labs. This role will oversee high-priority initiatives across the commercial vaccine testing portfolio, including instrument replacements, method replacements, analytical method transfers, method validation and implementation support, equipment qualification, and method modernization. The role will be located in West Point, PA. The Associate Director will provide people leadership, project leadership, prioritization, and escalation support to ensure reliable, compliant, and sustainable vaccine analytical testing. The role requires strong collaboration across West Point Quality Laboratories, GQ-LMAS, manufacturing, technical support, engineering, development, Quality Assurance, CMC-Regulatory, and external laboratory partners. The successful candidate will be a strong scientific and project leader with experience in GMP Quality Control, vaccine analytical testing, method lifecycle management, and cross-functional execution in a fast-paced laboratory environment.

Education Minimum Requirement

Bachelor’s degree with eight (8) years, Master’s degree with six (6) years, or PhD with four (4) years of relevant experience in vaccine analytical testing, quality control, method validation, method transfer, technical operations, laboratory project execution, or project leadership.

Required Experience and Skills
  • Experience leading scientific or technical teams, including coaching, prioritization, performance management, and talent development.
  • Strong background in GMP Quality Control analytical testing, preferably supporting commercial vaccine products.
  • Experience with analytical method lifecycle management, method validation, method transfer, technical change implementation, and QC method sustainment.
  • Experience managing analytical projects across multiple vaccine programs, laboratories, or technical areas.
  • Experience with instrument replacement, equipment qualification, method replacement, method modernization, analytical transfer, or test method implementation projects.
  • Strong organizational, project management, communication, and escalation skills.
  • Ability to influence decisions and drive execution in a matrixed West Point site and global quality environment.
Preferred Experience and Skills
  • Experience supporting vaccine analytical testing in a West Point Quality Laboratory or comparable commercial vaccine QC environment.
  • Experience with vaccine analytical methods such as bioassays, immunoassays, chromatography, biochemical, biophysical, molecular, microbiological, or characterization methods.
  • Experience with deviations, laboratory investigations, change control, assay monitoring, data trending, continuous improvement, inspection readiness, or regulatory support.
Required Skills
  • Analytical Chemistry, Analytical Chemistry, Analytical Method Transfer, Bioanalytical Analysis, Bioanalytical Techniques, Budget Management, Data Analysis, Data Review, Design of Experiments (DOE), Deviation Investigations, Dosage Forms, Identifying Customer Needs, Immunoassays, Instrumental Analysis, Laboratory Research, Mentoring Staff, Method Development, Method Improvement, Method Validation, People Leadership, Process Improvements, Project Engineering, Project Management, Research Development, Technical Transfer {+ 4 more}

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

Salary

The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

The application deadline for this position is stated on this posting.

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Employment Details
  • Employee Status: Regular
  • Relocation: No relocation
  • VISA Sponsorship: No
  • Travel Requirements: 10%
  • Flexible Work Arrangements: Not Applicable
  • Shift: 1st - Day
  • Valid Driving License: No
  • Hazardous Material(s): NA

Job Posting End Date: 09/19/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

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